STERLING C9911Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854017722), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, C9911, STERLING SPHERICAL BUR, MICROBLADE, 2.9 MM, WAS USED DURING AN ARTHROSCOPIC CARPAL TUNNEL SYNDROME (CM) JOINT FORMATION PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿IMMEDIATELY AFTER STARTING TO USE THE ABRADER BUR UNDER ENDOSCOPIC GUIDANCE, THE BALL-SHAPED TIP OF THE BUR BROKE OFF AND DETACHED. WE HAVE RECEIVED A REPORT THAT THE DETACHED PART WAS REMOVED, SO THERE ARE NO REMAINING REMNANTS IN THE BODY, AND THERE IS NO IMPACT ON THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712356 ↗